Auditor Network Development Specialist

4 days ago


Ellesmere Port, Cheshire, United Kingdom SGS Full time

We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.

Job Description

Auditor Network Development Specialist (Lead/Trainee Auditor)

The role involves supporting the development of our global medical device auditor network by aiding the qualification of trainee auditors. This includes witnessing qualification audits, providing formal and informal feedback on trainee performance, delivering training, and coaching.

  1. Support the expansion and development of our IVDR certification service across our global network.
  2. Act as a key point of contact for our medical device offices, mentor junior colleagues, and help coordinate the expansion of the IVDR auditor network.
  3. Contribute to the continuous improvement of processes and tools used across our network to conduct IVDR conformity assessments.
  4. Conduct audits at clients' sites and remotely, following established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
  5. Work alone or lead audit teams as appropriate, enhance client satisfaction, and ensure compliance with standards and regulatory requirements.
  6. Complete specific projects about medical device procedures, processes, systems, and documentation as requested by the Medical Devices Manager.
Qualifications

To be considered for this role, please submit your English CV.

  1. Previous auditing experience within an IVD or IVDR notified body is mandatory.
  2. A minimum of 4 years 'hands-on' professional experience of designing, manufacturing, or testing of IVDs.

Key skills include:

  • EU IVDR 2017/746 knowledge
  • Standards and guidance documents relevant to in-vitro diagnostic medical devices

In addition:

  • Experience of working under own initiative and in planning and prioritising workloads.
  • Willingness to travel internationally as required.
  • Good English written and verbal skills.
Estimated Salary: $120,000 - $180,000 per year

This estimate is based on industry standards and may vary depending on location and qualifications.



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